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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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 Class 2 Recall
Philips
see related information
Date Posted March 15, 2012
Recall Status1 Open
Recall Number Z-1216-2012
Recall Event ID 61204
Premarket Notification
510(K) Number
K031535 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034 Product Usage: Radiological image processing system (computed radiography x-ray system)
Code Information DRF systems with software reI 3.0 and 3.1 S/N: 362600 362601 364209 364210 375245 375850 376439 416254/SN09000007 417890/SN08000120 384396 401281/SN08000142 399440 387492 399621 398185 423047 399623 422094 422823 412477/SN08000137 425981 402409 402410/SN08000112 428620 428623 426466 426467 404548/SN08000110 417116/SN08000126 410563/SN08000120 408593/SN08000103 408592/SN08000111 408237/SN08000115 409087/SN08000107 435412 413514/SN08000123 413831/SN08000122 422648 422650 422652 414463 416393/SN08000140 416643/SN09000005 420212 421780 420872/SN09000003 425745 425744 427503 435926 430916 H706034090029 429498 431820 435419 439922 432277 435422
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall
Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare sent an Urgent Medical Device Correction letter dated February 8, 2012 to all affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter contains important information for continue safe and proper use of the equipment. Philips will contact customers to schedule the installation of the updated software. For further information or support contact your local Philips representative at the Technical Support Line 866-767-2822.
Quantity in Commerce 60 units
Distribution Worldwide Distribution - USA Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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